MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VIDEOSCOPE CABLE EXERA II

Model Number MAJ-1430

Device Problems Break (1069); Electrical /Electronic Property Problem (1198); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2023

Event Type  malfunction  

Event Description

The customer reported part that plugs is missing a pin from the inside of the videoscope cable exera ii.The issue was found during an unspecified diagnostic procedure.There were no reports of patient or user harm associated with this event.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: flickering/intermittent image.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found bad scope connector caused a failed continuity test, flickering/intermittent image due to faulty cable, unit.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause of the reported flickering/intermittent image issue could not be determined, however, it is likely that the issue was the result of a faulty video cable due to repetitive use stress, user handling/mishandling.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEOSCOPE CABLE EXERA II
• Type of Device: SCOPE CABLE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18226234
• MDR Text Key: 329214701
• Report Number: 3002808148-2023-13416
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170214509
• UDI-Public: 04953170214509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-1430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1